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510(k) Data Aggregation

    K Number
    K980357
    Device Name
    KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
    Manufacturer
    KONAN, INC.
    Date Cleared
    1998-04-24

    (85 days)

    Product Code
    HKI, NOE
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a noncontact ophthalmic microscope and ccamera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical reans. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
    Device Description
    The Noncon Robo Pachy specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo, K950091. The device permits visual inspection and photography of corneal endothelium and measurement of the corneal the thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
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